Tag Archives: “Office of Alternative Medicine”

——————————————————————The American Medical Establishment
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The medical establishment of the United States is very undemocratic – to put it mildly
Now, this is a guy coming from Taiwan in 1984
Under Chiang Kai-shek, we still had martial law at that time
So, you cannot speak your mind, otherwise you would find yourself in jail, or in a very “hot position”
So, in a way, I came to this country for higher education, is because I was quite vocal against “KMT” (Kuomintang), or Chiang Kai-shek
My parents and other relatives, they had managerial positions, and they all had to be members of the party
So they don’t like me to speak too loud about anything against the party
So I said, “alright, I’ll go to the United States anyway”
So, I come here
I went to University of Kentucky to get my PhD
And then, after writing the report on Burzynski, I suddenly find myself: Gee, it’s a “kiss of death” to my professional career — because, look at JAMA
——————————————————————Special CommunicationJournal of the American Medical Association (JAMA) – June 3, 1992
‘Antineoplastons’
An Unproven Cancer Therapy
Saul Green, PhD
——————————————————————JAMA could print a comment criticizing Burzynski, and now I’m writing a report, a report saying that Antineoplaston has some merit to it, and you’ve got to look into it
——————————————————————Evaluation of the Anticancer Activities of Antineoplastons and Related Compounds, Including Phenylacetate, Phenylacetylglutamine, 3-Phenylacetylamino-2, 6-piperidinedione and their respective Analogs

Li-Chuan Chin, Ph.D.
Office of Alternative Medicine
National Institutes of Health
October 24, 199?
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So halfway through writing the report, it suddenly dawned on me, that might be the end of my professional career, because they’re a bunch of academic professors, they wrote things ferociously bad
——————————————————————Oncologists criticize methods used in researching cancer treatment

Published Thursday, October 1, 1998
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about Burzynski’sAntineoplastons, and I have evidence and a report to say: “Antineoplaston worth a second look”
How would they view me – professionally ?
And so I know in my heart that that’s the end of my professional career
——————————————————————NCI: The National Cancer InstituteNIH: The National Institutes of Health
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The National Cancer Institute and the National Institutes of Health:
I found it’s a place full of people with ego of titanic proportions
You know, they are all like working for their career, working for their fame and rich
Sometimes their hearts are not there for the patients
They are more interested in their own benefit, and in the end, that’s what I realized
So, it was a disappointment
You know, they say, NIH is the mega medical center
But when you look back at the past 10, 20 years — very few Nobel Prize winner come out of NIH
And they got all the budget
They got all the money to do research
So even if you give me $1 million dollars to go back to NIH, I won’t
I won’t
I wouldn’t do anything against my conscience
——————————————————————A two-party medical system ?
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So, eventually what I found out is that the culture is “split in two”
One is “orthodox”
The other one is “alternative”
You’ve got this “orthodox culture,” and then there’s a culture living around it
And it’s fascinating
Politically, it’s like, well, you have the dominant party, and they rule the country, and there are fringe groups and opposition parties here and there, you know
And if the authorities are not too harsh on them, sometimes they got a niche — they are surviving (laughing)
You know, it’s, in some ways to me, it’s very interesting cultural phenomenon
Yeah
And finding that in a democratic country like United States, and you
have this medical tyranny there
In tyrannies, or in authoritarian societies, a lot of the time, people would refrain from speaking the truth
Ok
The atmosphere is there to prevent you speaking your mind
Even if you see the truth
The scare tactic is enough to force a lot of people not to speak the truth within the medical field
If that fear is there, people will do things to avoid harm to their professional life, to their family life, to them personally
And it’ll perpetuate the fear for ever and ever
So it’s very difficult to delineate, say, “ahhh, it’s because of the health industry,” “it’s because of pharmaceutical companies,” the (?) of whatever
——————————————————————Utilizing the two-party medical system
——————————————————————What is your opinion, like if we wanna sort of get ourselves out of this mess?
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Well my opinion is this:
If I was President of a country I would split my health budget in research into two portions
One for the medical establishment
One for the alternative field
And I’d say, “in the end of the day,” or “in the end of the year, come and show me the result”
If you get better results than the other, then I’ll take the portion of budget out a little bit and put it into yours
Put into the winners
And if you continue to lose, you lose your budget
If there’s two-party system, like, in democracy, often time, let’s have two-party system in medicine, and let them run with the budget, and come back in the end and say: “Which cat catches the most mice”?
And this is what the general population wants
——————————————————————
Clip from the 2nd DVD ofBurzynski Cancer Is Serious Business
2 DVD Extended Edition Set
7:44
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Dr. Friedman asked me to respond to your letter of 3/29/1995 regarding the change we have been considering in eligibility criteria for the Memorial Sloan-Kettering and Mayo Clinic phase II studies of antineoplastons

At the investigator’s request, the amendments to modify the eligibility restrictions for size of tumor, number of tumors, and leptomeningeal spread, and to allow entry of patients with KPS of 60, have been approved

These amendments were initiated by the investigators when it became apparent that many good candidates for the study were being excluded because of what were perceived to be overly stringent and unnecessary eligibility restrictions

Approximately a year ago, we wrote to you asking for your concurrence to make similar changes to the protocol

(see enclosed letter)

We have documented that the revised eligibility criteria are consistent with those used in your very own protocols that employ identical or nearly identical treatment regimens

Furthermore, in a review of the 7 patients in the best case series presented to NCI, we have found that perhaps 4 of the 7 patients who apparently had tumor shrinkage would not have been eligible to enter the NCI phase II studies under the original stringent eligibility criteria

(see attached)

These types of patients will now be eligible for study using the revised eligibility criteria proposed by the investigators and recently approved by CTEP

Despite the difficulties in accrual, we are committed to completing the phase II evaluation of the antineoplastons

Our goals remain unchanged, that is, we wish to determine whether the drugs used in the similar manner as you recommend, and in the similar population of patients, will yield results consistent with those in the best case series

As noted above, our careful evaluation of the materials you have provided indicate that the amendments to the eligibility criteria do not deviate from the eligibility criteria and methods you have employed in your experience

We would appreciate the opportunity to review your data, alluded to in your letter, that support the contention that inclusion of theses patients requires a different treatment regimen or is unsafe

In the meantime, we will allow the amendments to stand, since all evidence you have provided to date indicates that these newly eligible patients may have a chance for benefit without undue risk of harm, and are appropriate candidates for evaluation of the drug

We will forward the data on the 1st 5 patients in a separate mailing as you requested

Pg. 2

However, you have asked that we suspend accrual while you review the data

There is no medical or regulatory reason to suspend accrual at this time

Suspending accrual will likely further damage the efforts the investigators have made to increase accrual to the trial

In response to your letter of 10/20/1993, it is difficult for me to understand why the entire 1st page of your letter is used to discuss the simplest issue:

that adults should use a different dosage than that used for children

Since you agreed to the study procedure of Protocol BT-6 as recommended in my letter of 6/9/1993, we have not requested any changes in the structure of treatment which was accepted by Memorial-Sloan-Kettering Cancer Center (MSKCC)

As you confirmed in your letter of 10/20/1993, you know very well that since 4/1/1993 of this year my recommended dosage of Antineoplaston AS2-1 for adults is 0.4g/kg/24h

Again, I confirmed that this is the right dosage for adults in my letter to Dr. Shoemaker of 8/24/1993

Yet, for no apparent reason, you insist on using in the adult treatment protocol the dosage 0.6g/kg/24h which I recommend for children

It is generally known that a child’s body weight is much lower than that of adults

This should be reflected in the escalation of the dosages

My recommendation as to how to escalate the dosages for adults was submitted to the NCI on 6/4/1992

Yet, for no apparent reason the MSKCC protocol, which is designed for adults, escalates the dosages in the small increments recommended for children

The principle behind dose escalation is to accomplish the maximum dosage in 3 to 5 days, not 3 to 4 weeks, which would expose the patient to the unnecessary risk of tumor progression

I appreciate very much that you have finally decided to follow my recommendation regarding dosage and dosage escalation

Regarding the number of patients to be treated at MSKCC, the contradictory, incomplete, and inconsistent information is being supplied by you

The MSKCC’s protocol of 4/16/1993, 7/13/1993, and 8/30/1993 describe the treatment of 35,

Pg. 2

but not 70 patients

(please see paragraph 12.1, pg. 10 of the protocol, which is attached)

It was our understanding that 35 patients would be treated at MSKCC and at the Mayo Clinic

I never agreed for the treatment of 70 patients at MSKCC

Since I have to produce the medicine for the trial and pay for it, it is vitally important to me to know how many patients will be treated

The treatment of an additional 35 patients may cost up to 2 million dollars

Contrary to the information given by NCI that we received the money for the production of medicine, this money went apparently into a “black hole”

(“Black Holism,” The Village Voice, 7/29/1993, enclosed)

We have received none of the money which the Office of Alternative Medicine gave to the NCI for funding the trials with our medicine

Contrary to the opinion expressed in your letter, we see no reason for modifying Fleming’s Phase II clinical trial design and introducing more stringent than usual criteria for response evaluation

We request that Fleming’s original design be used, which calls for the initial treatment of 15 patients with at least one responder, instead of 20 patients and 2 responders

Given the fact that there is no existing treatment effective in this type of cancer, one responder in 15 is certainly significant and would be reason enough to expand the trial

I found your your requirement for 14 days to complete scans and laboratory tests prior to treatment very interesting

It is a very well known fact that glioblastoma multiforme is such an active tumor that if 2 weeks elapses from the time of the scan and the beginning of treatment, the tumor may increase by more than 50%

This means that even before the patient begins treatment, he can be classified as an increasing disease case

In most of the hospitals in the U.S., including out tiny clinic, all pretreatment tests including the scans can be done in one day

Therefore, I insist that the pretreatment evaluation, including brain scans, be done within 7 days from the time treatment begins

Regarding the Karnofsky Performance Status (PS), it is unclear to me why you have backed off from your own recommendation in your letter of 5/5/1993 (copy attached) that “patients with Karnofsky PS of below 70% should be excluded”

I am requesting that as recommended by NCI, the patient’s PS should be 70% to 100%

I agree that both scan data and neurological assessment can be described in the analysis of response, but the decision of how to classify response should be based on tumor measurements alone

All of these patients will have been extensively treated before

As the result of previous neurotoxic treatments, a number of these patients will deteriorate neurologically even if the Antineoplastons eradicate the

Pg. 3

tumor

The purpose of the protocol is to evaluate the antitumor effect, not to prove that Antineoplastons can repair brain damage resulting from chemotherapy and radiation

In this 1st independent study with Antineoplastons, in order to assure that patients will derive the most benefit from the treatment, it is critically important to schedule more frequent evaluations of the data than waiting until after the accrual of 14 patients, i.e. waiting 9 months

(Based on an accrual of 2 patients per month, if we wait until 14 patients are accrued and treated, 9 months will pass before the 1st evaluation takes place)

Therefore, I request that reviews of the studies be performed after the treatment of each group of 5 patients, i.e. after 6 months

I agree, however, that you will provide the Theradex printout to us as you receive it

In addition to patient welfare, there is another reason for more frequent patient evaluations

As you stated in your letter, I have no doubt that the investigators at MSKCC have extensive experience treating glioma

However, MSKCC is known to be biased against Antineoplastons

At least 3 researchers associated with MSKCC published willful misrepresentations and distortions about Antineoplaston research

Because of the controversial nature of the upcoming Antineoplaston clinical trials, it is essential that they are conducted in a manner beyond any suspicion of bias

Contrary to the opinion expressed in your letter, NCI is responsible for the trial’s delay

As you well know, the NCI selected an MSKCC investigator in 9/1992

In spite of our repeated requests, 8 months were waisted before the NCI produced the 1st draft of the protocol

As promised in my letter to you of 11/11/1992, the supply of Antineoplastons has been prepared and was shown to Ms. Mary McCabe of NCI during the site visit on 2/9/1993

The medicine was ready to be released pending final approval approval of the labels by the FDA and our final QC inspection

The medicine will be sent to you immediately once you make the corrections to the protocol that we have requested

Since you mentioned that patient recruitment has begun already, I would be glad to accept these patients immediately under my care and offer them free medicine as we wait for the protocol to be revised and the treatment at MSKCC to begin

The MSKCC protocol in its current form would threaten the welfare of these patients

In your letter you stated that your mission is to find and develop better therapies for cancer patients, and that your only obligation is to those patients

However, the way

Pg. 4

you proceed leads me to question that for the following reasons:

1) Out of numerous cancer treatment centers, you selected 2:

MSKCC and Mayo Clinic, which are known to be strongly biased against alternative treatments

In the past doctors associated with MSKCC have voiced strong opposition to Antineoplaston therapy and have published articles full of misrepresentations and distortions

2) The protocol approved by you will allow the disease to progress between the pretreatment evaluation and the beginning of treatment

3) Due to the slow escalation of dosages, patients will most likely have marked increase of tumor size beginning the treatment at the correct dosage level

4) In spite of my numerous requests (letters of 4/29/1993, 6/9/1993, and 8/24/1993) to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991 to have a separate clinical trial for glioblastoma multiforme and anaplastic astrocytoma, you continue to combine both types of tumors together

Even in your most recent stratification strategy submitted to the FDA, you are planning to treat initially 20 patients without specifying whether those 20 patients are per each stratum (glioblastoma vs. anaplastic astrocytoma), or whether this initial group of 20 patients consist of a mixture of glioblastoma and anaplastic astrocytoma

If the latter is the case, then we can expect that among these 1st 20 patients, most will have glioblastoma, which is more common and more difficult to treat

In case of treatment failure in these 20 patients, it will be easy to make the statement that Antineoplastons do not have therapeutic effect in both tumor categories

5) The protocol now states in paragraph 10.2, 10.3, and 10.4 that the objective decrease of tumor size is not enough to be considered a true response to treatment, that there must also be improvement in neurological function

As I explained in my letter of 10/13/1993 to Dr. Greenblatt, it is not unusual in my practice to see patients whose tumor has disappeared, but who have deteriorated neurologically as the result of delayed toxicity from radiation therapy and chemotherapy

Since these patients in the MSKCC study have been pretreated, and since there has been no indication that anything, including Antineoplastons, can repair brain damage caused by chemotherapy and radiation, I request that the criteria including restored neurological functioning be removed from paragraphs 10.2, 10.3, and 10.4 of the protocol

Pg, 5

6) Finally, by limiting our access to the data and not allowing review until after the 1st 14 patients have been treated, it would be easy to deviate from the protocol and supply inadequate treatment, and then claim that due to the the failure of the 1st 14 patients it would be a waste of the taxpayers money to proceed with further treatment

Your final statements that you are ready to proceed with the treatment with Antineoplastons without our participation caught me by surprise

It is hard to imagine that a Federal employee would consider patent infringement, thus infringing on the patent rights of thousands of our shareholders

Once again, I urge you to take our requests seriously, honor the guidelines of the NCI’s Decision Network on 12/2/1991, and make proper corrections to the protocol, so that objective clinical studies can begin immediately

In the meantime, I would be glad to treat for free all the patients presently recruited, and will submit progress reports weekly for the NCI’s review and evaluation